Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 30
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- Baha 5 Power Sound Processor (K161123): indications, design and recorded evidenceRegulatory decision evidence
- Balloon Catheter and Balloon Ureteral Dilator Set (K172588): indications, design and recorded evidenceRegulatory decision evidence
- Balloon, Nasal Airway (QGK) — FDA decisions, comparisons and evidenceFDA record research
- Bambino 3, S3 and S3 Swing, U3 and U3 Light, X (K220698): indications, design and recorded evidenceRegulatory decision evidence
- Bandit guidewire (K181647): indications, design and recorded evidenceRegulatory decision evidence
- Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (K250098): indications, design and recorded evidenceRegulatory decision evidence
- Bard® Mesh; Bard® Mesh Pre-Shaped (K251557): indications, design and recorded evidenceRegulatory decision evidence
- Barrier Sleeves (K191448): indications, design and recorded evidenceRegulatory decision evidence
- Barrier, Animal Source, Intraoral (NPL) — FDA decisions, comparisons and evidenceFDA record research
- Battery-Powered Instruments Charged Through Sterile Barriers (SAM) — FDA decisions, comparisons and evidenceFDA record research
- BcSs-PICNI-2000 Sensor (K182073): indications, design and recorded evidenceRegulatory decision evidence
- Beacon EUS Access System (K180037): indications, design and recorded evidenceRegulatory decision evidence
- BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) (K232738): indications, design and recorded evidenceRegulatory decision evidence
- Bed-Patient Activity Monitoring System (SBO) — FDA decisions, comparisons and evidenceFDA record research
- BedDot (G1) (K253274): indications, design and recorded evidenceRegulatory decision evidence
- Bencox THR System (K211866): indications, design and recorded evidenceRegulatory decision evidence
- Bendit17 Microcatheter (K252213): indications, design and recorded evidenceRegulatory decision evidence
- Bendit21 Microcatheter (K203842): indications, design and recorded evidenceRegulatory decision evidence
- BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 (K202405): indications, design and recorded evidenceRegulatory decision evidence
- Besmed Peak Flow Meter (K172804): indications, design and recorded evidenceRegulatory decision evidence
- Beta-CrossLaps CalCheck 5 (K170678): indications, design and recorded evidenceRegulatory decision evidence
- BethaLoc® stem cementless HA (K223103): indications, design and recorded evidenceRegulatory decision evidence
- BiWaze Clear System (K260604): indications, design and recorded evidenceRegulatory decision evidence
- BiWaze Cough (K191912): indications, design and recorded evidenceRegulatory decision evidence
- Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (K243786): indications, design and recorded evidenceRegulatory decision evidence
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